S-Caine™ Peel (Skin Numbing Cream) to Treat Pain During Laser-Assisted Tattoo Removal in Adults

Pain Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo Controlled, Paired Study Evaluating S-Caine™ Peel (Lidocaine 7% and Tetracaine 7% Cream) for Induction of Local Dermal Anesthesia for Laser-Assisted Tattoo Removal in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110734
• Other study ID #: SCP-43-05
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2005
• Last updated: September 21, 2005
• Est. completion date: September 2005

Study information

• Verified date: September 2005
• Source: ZARS Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

There is pain associated with laser-assisted tattoo removal. For this reason, some form of anesthesia is commonly used to eliminate or minimize the pain. This anesthesia is usually a topical local anesthetic cream or ointment spread over the skin. The purpose of this study is to further estimate the effectiveness of S-Caine™ Peel (lidocaine 7% and tetracaine 7% cream) for treating pain during laser-assisted tattoo removal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient is 18 years of age or older

• Patient elects to undergo laser-assisted tattoo removal

Exclusion Criteria:

• Patient is pregnant or breastfeeding

• Patient has participated in a clinical trial of an unapproved drug within the previous 30 days

• Patient has participated in any previous clinical trial involving S-Caine Peel

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• S-Caine™ Peel (lidocaine and tetracaine cream 7%/7%)

Locations

Country	Name	City	State
United States	Laser and Skin Surgery Center of New York	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
ZARS Pharma Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the efficacy of S-Caine Peel when applied for 60 minutes for induction of local dermal anesthesia prior to laser-assisted tattoo removal in adults
Secondary	To monitor the nature and frequency of adverse events (AEs) associated with the application of S-Caine Peel